Senior Quality Assurance Specialist

Empower Pharmacy; Houston (TX); On-site; USD 100,000 - 130,000; Full time

Job summary

Empower Pharmacy in Houston, TX is seeking a Senior Quality Assurance Specialist to strengthen site quality oversight, drive inspection readiness, and ensure supplier reliability in a fast-growing, highly regulated 503A/503B environment.

You will lead complex audits, coordinate external assessments, and advance risk-based qualification and monitoring of critical suppliers, while coaching cross-functional teams to sustain cGMP adherence and continuous quality improvements.”

Qualifications

• At least 5 years of quality experience within pharmaceutical manufacturing, with a strong understanding of cGMP requirements and regulatory compliance required.
• A bachelor’s degree in life sciences, pharmaceutical sciences, or a related discipline, or equivalent work experience demonstrating relevant quality expertise required.
• Experience leading audits or inspection preparation, coordinating cross-functional responses, and following corrective actions through implementation and documented verification of effectiveness required.
• Certified Quality Auditor (CQA) or Certified Quality Improvement Associate (CQIA) certification relevant to auditing and quality improvement responsibilities strongly preferred.

Responsibilities

• Lead preparation and execution for regulatory inspections, customer audits, and external assessments, coordinating subject-matter experts, accurate responses, and timely commitment completion.
• Develop risk-based internal audit plans, lead complex audits, evaluate systemic compliance risks, and prepare reports documenting findings and required actions.
• Lead risk-based qualification, auditing, and approval of critical suppliers and service providers, evaluating capabilities, compliance history, and business and patient risks.
• Evaluate root-cause analyses and corrective action plans, oversee implementation, and verify effectiveness to support sustainable resolution of audit findings and supplier issues.
• Review quality documentation for accuracy and completeness, using batch record knowledge and Microsoft Office tools to support audit preparation and reporting.
• Deliver training and coaching on compliance gaps and remediation requirements, strengthening cross-functional understanding, execution discipline, and accountability for commitments.

Skills

cGMP compliance

Regulatory compliance

Auditing

Root cause analysis

Documentation

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

Job description

Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation's most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we’re redefining what’s possible in personalized medicine and pharmaceutical manufacturing. We’re proud to be recognized as one of Houston’s fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc. 5000 List for 2025.

Our strength is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we’ve created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care. From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country.

At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that’s transforming healthcare at scale. We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions.

If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you. Let’s transform healthcare together.

POSITION OVERVIEW:

The Senior Quality Assurance Specialist strengthens site quality oversight, inspection readiness, and supplier reliability across Empower’s pharmaceutical manufacturing operations. Operating in a hyper-growth, highly regulated 503A/503B environment, this individual contributor leads complex audits, coordinates external assessments, and advances risk-based qualification and monitoring of critical suppliers and service providers. The role owns assigned audit preparation, response coordination, and follow-through on corrective actions, protecting product quality and patient safety through accurate documentation and verified effectiveness. Success requires strategic prioritization, disciplined execution, sound judgment, and the ability to learn quickly as requirements and operational needs evolve. Through cross-functional influence, training, and coaching, the specialist identifies systemic compliance gaps, strengthens current Good Manufacturing Practices (cGMP) adherence, and delivers sustainable improvements while ensuring all assigned inspection and supplier commitments are completed accurately and on schedule.

RESPONSIBILITIES

Inspection Readiness and Audit Execution

• External Assessments : Lead preparation and execution for regulatory inspections, customer audits, and external assessments, coordinating subject-matter experts, accurate responses, and timely commitment completion.
• Internal Audits: Develop risk-based internal audit plans, lead complex audits, evaluate systemic compliance risks, and prepare reports documenting findings and required actions.
• Readiness Assessments: Lead inspection-readiness assessments to identify systemic gaps and emerging compliance risks, prioritize remediation, and align cross-functional actions with site needs.

Supplier Qualification and Risk Management

• Supplier Qualification: Lead risk-based qualification, auditing, and approval of critical suppliers and service providers, evaluating capabilities, compliance history, and business and patient risks.
• Supplier Monitoring: Monitor supplier quality performance and compliance trends, identify emerging risks, and recommend supplier status changes based on documented assessment findings.
• Supplier Investigations: Lead investigations into significant supplier deficiencies and quality events, determining when supplier corrective action requests (SCARs) or escalation are required.

Corrective Actions and Quality Improvement

• Corrective Actions: Evaluate root-cause analyses and corrective action plans, oversee implementation, and verify effectiveness to support sustainable resolution of audit findings and supplier issues.
• Documentation Accuracy: Review quality documentation for accuracy and completeness, using batch record knowledge and Microsoft Office tools to support audit preparation and reporting.
• Compliance Coaching: Deliver training and coaching on compliance gaps and remediation requirements, strengthening cross-functional understanding, execution discipline, and accountability for commitments.

KNOWLEDGE AND SKILLS:

• Strong knowledge of cGMP requirements, regulatory compliance, inspection readiness, and risk-based auditing methods applicable to pharmaceutical manufacturing and site quality oversight.
• Ability to assess supplier capabilities, compliance history, and quality performance, translating business and patient risks into qualification, monitoring, and escalation decisions.
• Proficiency in root-cause analysis tools, corrective action evaluation, documentation review, and batch record flow, with working knowledge of Microsoft Office tools.
• Clear written and verbal communication, cross-functional influence, and coaching skills to coordinate subject-matter experts, explain complex findings, and sustain remediation commitments.

EXPERIENCE AND QUALIFICATIONS:

• At least 5 years of quality experience within pharmaceutical manufacturing, with a strong understanding of cGMP requirements and regulatory compliance required.
• A bachelor’s degree in life sciences, pharmaceutical sciences, or a related discipline, or equivalent work experience demonstrating relevant quality expertise required.
• Experience leading audits or inspection preparation, coordinating cross-functional responses, and following corrective actions through implementation and documented verification of effectiveness required.
• Certified Quality Auditor (CQA) or Certified Quality Improvement Associate (CQIA) certification relevant to auditing and quality improvement responsibilities strongly preferred.

KEY COMPETENCIES:

• Customer Focus: Builds trust through customer-centric solutions.
• Strategic AI: Guides responsible AI adoption and adaptation.
• Optimizes Work Processes: Drives efficiency with continuous improvement.
• Collaborates: Partners effectively to achieve shared goals.
• Resourcefulness: Secures and deploys resources efficiently.
• Manages Complexity: Simplifies and solves complex challenges.
• Ensures Accountability: Delivers on commitments with integrity.
• Situational Adaptability: Adjusts approach to shifting conditions.
• Communicates Effectively: Tailors messages to diverse audiences.

VALUES:

• People: Empowering people defines who we are.
• Quality: Excellence in every product, every time.
• Service: Serving others is our highest purpose.
• Innovation: Advancing care through technology and discovery.

EMPLOYEE BENEFITS, HEALTH AND WELLNESS:

We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/

PHYSICAL REQUIREMENTS:

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.